Using parameter variation to guide blood pressure and circulation during major abdominal surgery
A NEW APPROACH IN THE MANAGEMENT OF INTRAOPERATIVE ARTERIAL HYPOTENSION BASED ON DELTA VARIATION OF HEMODYNAMIC PARAMETERS: A RANDOMISED CLINICAL TRIAL
NA · Fondazione Policlinico Universitario Agostino Gemelli IRCCS · NCT06932484
This study will test whether using percentage changes in monitoring parameters during major abdominal surgery can help keep blood pressure and circulation stable in adults.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 104 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS (other) |
| Locations | 1 site (Rome, RM) |
| Trial ID | NCT06932484 on ClinicalTrials.gov |
What this trial studies
This interventional protocol uses intraoperative hemodynamic optimization driven by the percentage variation of selected monitoring parameters to maintain mean arterial pressure stability. Adult patients scheduled for elective major abdominal surgery will have management guided by these dynamic parameter thresholds during the operation. Key exclusions include a BMI over 35 kg/m2, pregnancy, refusal of consent, and urgent or emergency procedures. The work is conducted at a single academic center in Rome and focuses on immediate intraoperative hemodynamic outcomes.
Who should consider this trial
Good fit: Adults over 18 years old who are scheduled for elective major abdominal surgery and can provide informed consent are the intended participants.
Not a fit: Patients with BMI over 35 kg/m2, pregnant patients, those undergoing urgent or emergency surgery, or those who decline consent are unlikely to receive benefit from this protocol.
Why it matters
Potential benefit: If successful, this approach could reduce intraoperative blood pressure swings and improve organ perfusion during major abdominal surgery.
How similar studies have performed: Similar approaches using dynamic variability parameters (such as pulse pressure or stroke volume variation) have shown benefit in guiding fluid and hemodynamic management, although results vary by clinical setting.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: All patients \> 18 years old scheduled for major abdominal Exclusion Criteria: Body Mass Index \> 35 kg/m2 Pregnancy Refusal to sign written informed consent Urgent and/or emergency surgery
Where this trial is running
Rome, RM
- Fondazione Policlinico Universitario Agostino Gemelli — Rome, RM, Italy (RECRUITING)
Study contacts
- Study coordinator: andrea russo, physician
- Email: andrea.russo@policlinicogemelli.it
- Phone: +39-06-30153212
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Hemodynamic MAP Stability